ACL Reconstruction Techniques for Anterior Cruciate Ligament Injury

Overseen By Whitney Hovater, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neuromuscular, Neurological, Fractures, Dislocations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

150 Participants Needed

Trial Summary

What is the purpose of this trial?

In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that ACL Reconstruction Techniques for Anterior Cruciate Ligament Injury (also known as: ACL Reconstruction) is an effective treatment?

The available research shows that ACL reconstruction techniques have improved over time, leading to better outcomes for patients. For example, studies have found that more accurate placement of the graft during surgery results in better stability and function of the knee. This means patients are more likely to return to their previous level of activity without pain. Additionally, ACL reconstruction is considered the 'gold standard' for restoring knee stability and function after an ACL injury, which suggests it is more effective than other treatments. The research also highlights that advancements in surgical techniques, such as anatomic reconstructions, have contributed to these positive outcomes. ^{1 2 3 4 5}

What safety data is available for ACL reconstruction?

Safety data for ACL reconstruction includes information on complications, infections, and adverse outcomes. Complications are well-documented and can vary based on the type of graft used. Infections, though rare, can lead to high morbidity. Rare complications may involve vascular injuries. Recent studies suggest that combined ACL and anterolateral reconstruction does not increase adverse outcomes. A large study of over 104,000 procedures highlights the importance of understanding risks for informed decision-making. ^{6 7 8 9 10}

Is ACL Reconstruction a promising treatment for ACL injuries?

Yes, ACL Reconstruction is a promising treatment for ACL injuries. Recent advancements in surgical techniques have improved the stability and function of the knee, helping patients return to their previous activity levels. These techniques aim to closely mimic the natural structure and function of the ACL, which can lead to better outcomes and prevent future knee problems. ^{1 4 11 12 13}

Research Team

Stephanie Mayer, MD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

This trial is for boys and girls aged 12-19 who need their first ACL reconstruction due to injury or tear. It's not for those with neuromuscular issues, neurological injuries, recent severe leg trauma, or systemic/musculoskeletal conditions.

Inclusion Criteria

I am either male or female.

I am between 12 and 19 years old.

I am having my first ACL surgery.

Exclusion Criteria

I have a diagnosis related to my body's systems or bones and muscles.

I had surgery for a leg injury within 2 years before my ACL injury.

You have a pre-existing neurological condition or injury affecting your muscles or nerves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative

Participants undergo ACL reconstruction using either the tendon-bone or all-soft-tissue graft technique and are monitored for immediate perioperative outcomes.

1-2 weeks

Rehabilitation and Intermediate Follow-up

Participants engage in physical therapy to achieve milestones related to return to sports clearance, with evaluations at 3, 6, and 12 months post-operative.

6 months to 1 year

Regular physical therapy visits

Long-term Follow-up

Participants are monitored for long-term outcomes including graft failure rate and patient-reported outcomes at 24 months and 5 years post-operative.

5 years

Follow-up visits at 24 months and 5 years

Treatment Details

Interventions

• ACL Reconstruction

Trial Overview The study compares two surgical techniques for pediatric ACL reconstruction: one using a tendon-bone graft and the other an all-tendon graft. The goal is to see which method leads to better outcomes in the short, medium, and long term.

Participant Groups

Group I: Tendon-Bone Graft Active Control 1 Intervention

Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.

Group II: All-Soft-Tissue Graft Active Control 1 Intervention

Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Findings from Research

Recent biomechanical studies indicate that more horizontal femoral tunnel placement in ACL reconstruction enhances rotational stability, which is crucial for knee function.

Clinical studies show that anatomic ACL reconstructions, which better mimic the natural ACL footprint, lead to improved patient outcomes compared to traditional techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning to anatomic anterior cruciate ligament graft placement. Sohn, DH., Garrett, WE.[2019]

ACL reconstruction is a common procedure for restoring knee stability, but improper graft placement can lead to failure, highlighting the need for precise surgical techniques.

This network meta-analysis aims to evaluate the clinical outcomes of various surgical techniques for ACL reconstruction, using a comprehensive set of outcome measures to inform patients and surgeons about the best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative risk-benefit profiles of different femoral drilling techniques in anterior cruciate ligament reconstruction: A protocol for a systematic review and network meta-analysis. Wang, N., Zhu, Z., Wu, Z., et al.[2022]

In a study of 21,686 ACL reconstructions from 2007 to 2014, surgeons significantly shifted their femoral tunnel drilling techniques, moving away from tibial tunnel drilling and increasing the use of medial and lateral portal drilling methods.

The use of first-generation bioabsorbable fixation decreased, while biocomposite fixation became more popular, yet the overall revision rates for ACL surgeries remained stable throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Technique Trends in Primary ACL Reconstruction from 2007 to 2014. Tibor, L., Chan, PH., Funahashi, TT., et al.[2022]

Recent advancements in knee ACL reconstruction focus on restoring the native anatomy and biomechanics of the ligament, aiming for a stable and pain-free knee joint that allows patients to return to their previous activity levels.

Innovations include a shift towards anatomic reconstruction techniques, a variety of graft options, and reinforcement methods like anterolateral ligament reconstruction, which collectively aim to reduce the risk of rerupture and prevent osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Major Technical Advances in Knee Anterior Cruciate Ligament Reconstruction Address Anatomy, Biomechanics, and Healing. Paschos, NK.[2022]

Most studies suggest that applying a graft tension of around 90 N during ACL reconstruction leads to the best outcomes, indicating the importance of proper tension for successful surgery.

Fixing the graft at a knee-flexion angle of 30° appears to provide superior biomechanical advantages, although there is no clear consensus on the best type of fixation implant for clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial-graft fixation methods on anterior cruciate ligament reconstructions: a literature review. Pereira, VL., Medeiros, JV., Nunes, GRS., et al.[2021]

In a study analyzing 104,255 ACL reconstructions over 20 years, serious complications occurred in only 0.65% of cases within 90 days, indicating a low overall risk of adverse events after surgery.

Approximately 3% of patients required further ACL reconstruction or meniscal surgery within 5 years, highlighting the importance of understanding potential long-term outcomes when making treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of Adverse Outcomes and Revision Surgery After Anterior Cruciate Ligament Reconstruction: A Study of 104,255 Procedures Using the National Hospital Episode Statistics Database for England, UK. Abram, SGF., Judge, A., Beard, DJ., et al.[2020]

In a study of 958 patients undergoing ACL reconstruction, the overall complication rate was 39%, with anterior knee pain, stiffness, and secondary meniscal lesions being the most common issues reported.

The patellar tendon graft showed a significantly lower rerupture rate compared to the hamstring graft (3.1% vs 7%), while complications related to hardware were more frequent in the hamstring group, suggesting that graft choice can impact postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. Rousseau, R., Labruyere, C., Kajetanek, C., et al.[2020]

ACL reconstruction is a generally safe and effective procedure for knee stability, but infections, although rare, can lead to serious complications and poor outcomes.

Early diagnosis and treatment of infections with culture-specific antibiotics and debridement are crucial to prevent further damage to the knee, while the type of graft used does not appear to influence infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. Stucken, C., Garras, DN., Shaner, JL., et al.[2022]

A young patient developed a rare complication, a pseudoaneurysm of the supero-lateral genicular artery, following an anterior cruciate ligament reconstruction combined with a meniscal suture, highlighting the potential risks associated with arthroscopic procedures.

The pseudoaneurysm was successfully treated using ultrasonography-guided embolization with thrombin, demonstrating an effective intervention for this uncommon complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudaneurysm of the superolateral genicular artery following an anterior cruciate ligament reconstruction. Glanz, L.[2021]

In a study of 224 patients, combining anterolateral ligament reconstruction (ALLR) with anterior cruciate ligament reconstruction (ACLR) showed a significantly lower rate of reoperations for cyclops syndrome compared to isolated ACLR (0% vs 8.9%).

The combined ACL + ALLR procedure did not increase the risk of adverse events and resulted in better subjective knee function scores, indicating it may be a safer and more effective option for ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Sonnery-Cottet, B., Pioger, C., Vieira, TD., et al.[2022]

The anterior cruciate ligament (ACL) is crucial for knee function, and its damage can lead to serious issues like joint degeneration, highlighting the importance of effective reconstruction techniques.

Current ACL reconstruction methods using autografts and allografts aim to replicate the biomechanical properties of the native ligament, with double-bundle techniques showing superior stability compared to single-bundle methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament (ACL) injuries: A review on the newest reconstruction techniques. Gerami, MH., Haghi, F., Pelarak, F., et al.[2022]

The transtibial technique for ACL reconstruction, while traditionally criticized for its limitations in creating anatomic femoral tunnels, can be modified to achieve better tunnel positioning and graft orientation.

This Technical Note outlines a refined approach to anatomic transtibial ACL reconstruction, potentially improving outcomes for patients undergoing this common orthopedic procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transtibial Anterior Cruciate Ligament Reconstruction: Tips for a Successful Anatomic Reconstruction. Manderle, BJ., Beletsky, A., Gorodischer, T., et al.[2022]

In a study of 100 patients undergoing ACL reconstruction, the All-Inside technique showed significantly better improvement in knee function and stability compared to the Anatomic Accessory Medial Portal technique, as measured by various clinical scores and tests.

The All-Inside technique resulted in superior scores on the IKDC Subjective Knee Score, Lysholm Knee Score, Knee Society Score, and Visual Analog Score, indicating it may be a more effective surgical option for ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of the Results of the Anatomic Medial Portal and All-inside Arthroscopic ACL Reconstruction. Shantanu, K., Kushwaha, SS., Kumar, D., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Transitioning to anatomic anterior cruciate ligament graft placement. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative risk-benefit profiles of different femoral drilling techniques in anterior cruciate ligament reconstruction: A protocol for a systematic review and network meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Surgical Technique Trends in Primary ACL Reconstruction from 2007 to 2014. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Major Technical Advances in Knee Anterior Cruciate Ligament Reconstruction Address Anatomy, Biomechanics, and Healing. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Tibial-graft fixation methods on anterior cruciate ligament reconstructions: a literature review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Rates of Adverse Outcomes and Revision Surgery After Anterior Cruciate Ligament Reconstruction: A Study of 104,255 Procedures Using the National Hospital Episode Statistics Database for England, UK. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Pseudaneurysm of the superolateral genicular artery following an anterior cruciate ligament reconstruction. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament (ACL) injuries: A review on the newest reconstruction techniques. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Transtibial Anterior Cruciate Ligament Reconstruction: Tips for a Successful Anatomic Reconstruction. [2022]

13. India pubmed.ncbi.nlm.nih.gov

A Comparative Study of the Results of the Anatomic Medial Portal and All-inside Arthroscopic ACL Reconstruction. [2020]